Acclimatization therapy for first time users

ABSTRACT

Systems, methods, and/or apparatuses for acclimatizing a user to positive airway pressure (PAP) therapy are provided. Generally, a sub-therapeutic treatment pressure is provided initially. It may be ramped up to a full treatment pressure over the course of one or more therapy sessions. The pressure level may be ramped up based on, for example, sleep state, sleep phase, patient compliance with types of treatment (e.g. bilevel vs. CPAP, etc.), clinician input (either at the site, remotely, via pre-programmed smartcards, etc.), etc. Such techniques may be used alone or in combination.

CROSS REFERENCE TO APPLICATIONS

This application claims the benefit of U.S. Provisional Patent No.60/935,885, filed Sep. 5, 2007 and incorporates by reference in itsentirety each of U.S. Provisional Patent No. 60/935,885, filed Sep. 5,2007, PCT Application No. PCT/AU06/00822, filed Jun. 14, 2006,Australian Application No. AU2005903089, filed Jun. 14, 2005, AustralianApplication No. AU2005906122, filed Nov. 4, 2005, and AustralianApplication No. AU2005906193.

FIELD OF THE INVENTION

The example embodiments described herein relate to mechanicalventilation of sleep disordered breathing (SDB), and in particular tomethods and apparatus for improving patient compliance in ContinuousPositive Airway Pressure (CPAP) treatment.

BACKGROUND OF THE INVENTION

A comprehensive background discussion of mechanical ventilation can befound in “Principles and Practice of Mechanical Ventilation” (1994)edited by Martin J. Tobin, published by McGraw-Hill Inc., ISBN0-07-064943-7.

The use of nasal Continuous Positive Airway Pressure (CPAP) to treatObstructive Sleep Apnea (OSA) was invented by Colin Sullivan, see U.S.Pat. No. 4,944,310. Generally, the treatment involves providing a supplyof air or breathable gas from a blower (sometimes referred to as a flowgenerator) to a patient via an air delivery conduit (e.g. a flexibletube) and a patient interface, such as, for example, a full-face ornasal mask, or nasal prongs. While treatment is effective, some patientsfind it uncomfortable. Improving patient comfort and compliance is acontinuing challenge.

One way to improve comfort is to provide a more comfortable patientinterface. In this regard, the ResMed MIRAGE™ masks have providedsignificant improvement in comfort. See U.S. Pat. Nos. 6,112,746;6,357,441; 6,581,602; and 6,634,358. A more recent development is theResMed MIRAGE™ ACTIVA™ mask series. See International Patent ApplicationWO 2001/97893.

In the early days of nasal CPAP systems for treating OSA, patients werefirst titrated in a clinical study to determine an optimal treatmentpressure. Titration involves a patient sleeping overnight in a clinicand being tested with a mask and CPAP device. The treatment pressureprovided by the CPAP device is adjusted until apneas are eliminated. Thetreatment pressure is usually in the range of 4-20 cmH₂0. A device wouldbe set to that pressure and given to the patient to take home. Asubsequent development was the automatically adjusting device that apatient could take home. The automatically adjusting device will raiseand/or lower the treatment pressure based on indications of obstructivesleep apnea, such as snoring. Such CPAP devices are sometime genericallyreferred to as Automatic Positive Airway Pressure (APAP) devices. SeeU.S. Pat. Nos. 5,245,995; 6,398,739; and 6,635,021.

Another form of automatically adjusting CPAP device is the ResMedAUTOSET™ SPIRIT™ device. In this device, the CPAP pressure isautomatically increased or decreased at least during patient inspirationin accordance with indications of flow limitation, such as flowflattening, snore, apnea, and hypopnea. See U.S. Pat. Nos. 5,704,345;6,029,665; 6,138,675; and 6,363,933. An advantage of an automaticallyadjusting system is that over time the treatment pressure required mayvary for a particular patient and a correctly functioning automaticsystem can obviate the need for the patient to return for a subsequentsleep study. These patents also describe a method and apparatus fordistinguishing between so-called “central” and obstructive apneas.

Another type of nasal CPAP device provides a first pressure duringinhalation (sometimes termed an IPAP) and a second, lower pressureduring exhalation (sometimes termed an EPAP). Examples of these includethe ResMed VPAP™ series, and the Respironics BiPAP series. Bilevel CPAPdevices may be prescribed for patients who do not comply with singlepressure CPAP devices. Some patients perceive that the lower pressureduring exhalation is more comfortable, at least while they are awake.

Another way of improving patient comfort and compliance is to start eachtherapy session at a low therapeutic pressure, e.g., 4 cmH₂O, and rampup to full therapeutic pressure over the first hour, to allow thepatient to adjust to the sensation while falling asleep. Alternatively,the device may set to implement a time delay before full therapeuticpressure is applied, to allow the patient time to fall asleep beforefull therapeutic pressure is applied. See U.S. Pat. Nos. 5,199,424 and5,522,382.

The contents of all of the aforesaid patents are incorporated herein bycross-reference in their entireties.

Some OSA patients find treatment with the above devices uncomfortableand they become non-compliant with the therapy. Other patients such ascardiovascular patients with Congestive Heart Failure, patients with REMHypoventilation, and patients with Respiratory Insufficiency could alsobenefit from a more comfortable and/or effective form of therapy.

One hurdle in patient compliance occurs in the initial stages oftreatment, where a patient may have difficulty in adjusting to thesensations of the therapy and may quit therapy before realizing thebenefits of the therapy.

A further hurdle to patient acceptance of the therapy is in the initialfitting of the patient interface (e.g., mask), where the mask fit istested under relatively low pressure and high flow. This may result innoisy operation of the device and high flow air leaks as the mask isadjusted to the patient, which can be a noisy and unsettling initialexperience for the patient.

Other impediments to patient comfort and compliance include thetreatment impeding the ability of the patient to communicate to theclinician or bed partner, or the patient or bed partner being disturbedby air leaks from the mask.

SUMMARY OF THE INVENTION

One aspect of the invention relates to a method and apparatus toovercome or ameliorate one or more of these disadvantages.

In certain example embodiments, a method of acclimatizing a patient toCPAP therapy for treatment of sleep-disordered breathing is provided. Adevice configured to supply pressurized breathable gas to the patientmay be provided. At least one smartcard also may be provided, with eachsmartcard having treatment parameters stored thereon. The device may beconfigured to accept the at least one smartcard and to provide thesupply of pressurized breathable gas based on the treatment parametersstored thereon.

In certain example embodiments, a CPAP device for acclimatizing apatient to treatment of sleep-disordered breathing is provided. The CPAPdevice may be operable to provide a supply pressurized breathable gas tothe patient based on treatment parameters stored on a smartcard, withthe smartcard being readable by the CPAP device.

In certain example embodiments, a smartcard for use with a deviceoperable to provide a supply of pressurized breathable gas to a patientis provided, with the smartcard having treatment parameters storedthereon, and the treatment parameters comprising a pressure setting tobe supplied to the device.

Certain example embodiments provide a method of acclimatizing a patientto CPAP therapy for treatment of sleep-disordered breathing. A deviceconfigured to supply pressurized breathable gas to the patient may beprovided. Target CPAP treatment parameters to be used when treating thepatient may be identified, with the target CPAP treatment parameterscomprising a full treatment pressure to be delivered to the patientduring patient inspiration and patient expiration. A bilevel treatmentmay be provided, with the bilevel treatment comprising providing IPAPtherapy and/or EPAP therapy. Parameters associated with the IPAP therapyand/or parameters associated with the EPAP therapy may be ramped upuntil the target CPAP treatment parameters are met.

Certain example embodiments provide a PAP device for acclimatizing apatient to treatment of sleep-disordered breathing. A flow generator maybe operable in acclimatization and CPAP modes to provide a supply ofpressurized breathable gas to the patient. A controller may be operableto instruct the flow generator, in the acclimatization mode, to providethe breathable gas at a first pressure during patient inspiration, andto provide the breathable gas at a second pressure during patientexpiration, with the second pressure being different from the firstpressure. The controller may be operable to adjust the first pressureand/or the second pressure until a target CPAP therapy is provided atwhich point the flow generator operates in the CPAP mode, with thetarget CPAP therapy having a full treatment pressure to be delivered tothe patient during patient inspiration and patient expiration associatedtherewith.

In certain other example embodiments, a method of acclimatizing apatient to therapy for treatment of sleep-disordered breathing isprovided. At least one parameter of the patient may be continuouslymonitored. The at least one parameter may be associated with acontinuously adjusting treatment pressure for the patient. A supply ofpressurized breathable gas may be provided to the patient at acontinuously adjusting pressure based on the at least parameter. Thebreathable gas initially may be provided at an adjustable limitedpressure, with the limited pressure being below the treatment pressure.The limited pressure may be ramped up during the treatment until thelimited pressure equals the treatment pressure.

In certain other example embodiments, a PAP device for acclimatizing apatient to treatment of sleep-disordered breathing is provided. Amonitor may be operable to continuously monitor at least one parameterof the patient. A processor may be operable to associate the at leastone parameter with a continuously adjusting treatment pressure. A flowgenerator may be operable to provide a supply of pressurized breathablegas to the patient at a continuously adjusting pressure based on the atleast one parameter. The flow generator may be configured to provide thebreathable gas at the treatment pressure and at a limited pressure, withthe limited pressure being below the treatment pressure. The flowgenerator may be operable to ramp up the limited pressure until thelimited pressure equals the treatment pressure.

Certain example embodiments provide a method of acclimatizing a patientto therapy for treatment of sleep-disordered breathing. At least oneparameter of the patient may be monitored. The at least one parametermay be associated with a treatment pressure for the patient. A supply ofpressurized breathable gas at the treatment pressure may be provided tothe patient. One or more obstructive events during the treatment may bedetected. For each obstructive event detected, the treatment pressuremay be incrementally increased a predetermined amount.

Certain example embodiments provide a PAP device for acclimatizing apatient to treatment of sleep-disordered breathing. A monitor may beoperable to monitor at least one parameter of the patient and operableto detect one or more obstructive events during treatment. A processormay be operable to associate the at least one parameter with a treatmentpressure. A flow generator may be operable to provide a supply ofpressurized breathable gas to the patient. The flow generator may beconfigured to incrementally increase the treatment pressure apredetermined amount for each obstructive event detected by the monitor.

Still further example embodiments relate to a method of acclimatizing apatient to therapy for treatment of sleep-disordered breathing. Thepatient may be observed to determine a full treatment pressureappropriate for the patient. A limited treatment pressure less than thefull treatment pressure may be determined. A supply of pressurizedbreathable gas may be provided to the patient at the limited treatmentpressure. At least one parameter of the patient may be monitored, withthe at least one parameter corresponding to patient acceptance of thetreatment. The at least one parameter may be communicated to a sleepclinician via a computer-mediated communication channel, the sleepclinician being located remote from the patient.

Still further example embodiments relate to a system for acclimatizing apatient to therapy for treatment of sleep-disordered breathing. A flowgenerator may be operable to provide a supply of pressurized breathablegas to the patient at a plurality of pressures. A sensor may be operableto monitor at least one parameter of the patient. A first communicatormay be operable to send the at least one parameter to a sleep clinician,and may be further operable to receive at least one treatment parameterfrom the sleep clinician. The sleep clinician may be located remote fromthe patient. The pressure of the breathable gas initially may beprovided at a limited treatment pressure less than a full treatmentpressure appropriate for the patient.

In still further example embodiments, a method of acclimatizing apatient to therapy for treatment of sleep-disordered breathing isprovided. A supply of pressurized breathable gas is provided through atube to a mask, with the mask having an opening therein, and with theopening allowing controlled mask leak. A size of the opening may beadjusted to alter an amount of mask leak and cause a correspondingchange in the breathable gas pressure. The size of the opening may beadjusted to vary a pressure of the breathable gas between a fulltreatment pressure and a limited pressure, with the limited pressurebeing less than the full treatment pressure.

In still further example embodiments, a mask for use by a patient duringtherapy for treatment of sleep-disordered breathing is provided. Themask may be configured to receive a supply of pressurized breathable gasfrom a tube connected to a flow generator. An opening may allowcontrolled mask leak. An adjustment mechanism may adjust a size of theopening to alter an amount of mask leak and for causing a correspondingchange in the breathable gas' pressure. The size of the opening may beconfigured to be adjusted to vary a pressure of the breathable gasbetween a full treatment pressure and a limited pressure, with thelimited pressure being less than the full treatment pressure.

In still further example embodiments, a system for acclimatizing apatient to therapy for treatment of sleep-disordered breathing isprovided. A flow generator may be operable to provide a supply ofpressurized breathable gas to the patient through a flexible tubeconnected to a mask. The mask may comprise an opening, the openingallowing controlled mask leak; and an adjustment mechanism for adjustinga size of the opening to alter an amount of mask leak and for causing acorresponding change in the breathable gas' pressure. The size of theopening may be configured to be adjusted to vary a pressure of thebreathable gas between a full treatment pressure and a limited pressure,with the limited pressure being less than the full treatment pressure.

Certain example embodiments provide a method of acclimatizing a patientto therapy for treatment of sleep-disordered breathing. A plurality offull treatment pressures may be provided, with each full treatmentpressure being associated with a sleep stage. The sleep stage of thepatient may be determined. A supply of pressurized breathable gas may beprovided to the patient in dependence on the sleep stage of the patient.

Certain example embodiments provide a PAP device for acclimatizing apatient to therapy for treatment of sleep-disordered breathing. A sensorfor determining a sleep stage of the patient may be provided, with eachsleep stage having a treatment pressure associated therewith. A flowgenerator may be operable to provide a supply of pressurized breathablegas to the patient in dependence on the sleep stage of the patient andconfigured to adjust the treatment pressure of the breathable gas if thesensor determines that the sleep stage of the patient changes.

Certain other example embodiments provide a method of acclimatizing apatient to therapy for treatment of sleep-disordered breathing. A supplyof pressurized breathable gas may be provided to the patient for apredetermined settling time at a limited pressure. The breathable gasmay be provided at a full treatment pressure after the predeterminedsettling time. The limited pressure may be lower than the full treatmentpressure.

Certain other example embodiments provide a system for acclimatizing apatient to therapy for treatment of sleep-disordered breathing. A flowgenerator may be operable to provide a supply of pressurized breathablegas to the patient for a predetermined settling time at a limitedpressure and operable to provide the breathable gas at a full treatmentpressure after the predetermined settling time. The limited pressure maybe lower than the full treatment pressure.

Still other example embodiments provide a method of acclimatizing apatient to therapy for treatment of sleep-disordered breathing. Thepatient may be treated using a PAP device. Patient compliance data maybe compiled during the treatment. The patient compliance data may beprocessed to identify problems associated with the treatment. Anyidentified problems may be compared to a solutions database.

Still other example embodiments provide a system for acclimatizing apatient to therapy for treatment of sleep-disordered breathing. A PAPdevice may be operable to provide a supply of pressurized breathable gasto the patient. A computer-mediated compliance monitoring package may beoperable to execute the following steps of compiling patient compliancedata during the treatment; processing the patient compliance data toidentify problems associated with the treatment; and, comparing anyidentified problems to a solutions database.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 illustrates a ventilator apparatus according to an exampleembodiment for implementing certain illustrative methods;

FIG. 2 is a flowchart illustrating an acclimatization therapy for newusers of CPAP treatment according to an example embodiment;

FIG. 3 is a flowchart of an acclimatization therapy for new CPAP usersaccording to an example embodiment;

FIG. 4 is an illustrative pressure vs. time graph for acclimatizationtherapy with an AutoSet device in accordance with an example embodiment;

FIG. 4A is a flowchart illustrating a process for remotely controllingacclimatization therapy in accordance with an example embodiment;

FIG. 5 is an illustrative view of a memory map embedded in a smartcardin accordance with an example embodiment;

FIG. 6A is an illustrative flowchart in which different pressures areprovided for the period in which a patient is falling asleep and theperiod in which the patient is asleep;

FIG. 6B is an illustrative flowchart in which different pressures areprovided for the period in which a patient is falling asleep and theperiod in which the patient is asleep, taking into account a mechanismfor delaying transition to the sleep period mode;

FIG. 7 is an illustrative flowchart showing a process for providing aset of pressures based on the patient's sleep stage in accordance withan example embodiment; and,

FIG. 8 is an illustrative flowchart showing how a bilevel device can bemade to provided CPAP therapy as a part of acclimatization therapy.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS 1. Illustrative Hardware

A positive airway pressure (PAP) device in accordance with an embodimentof the invention includes a blower and blower-controller. The blower candeliver a supply of air at positive pressure 2-40 cmH₂O, but generallydelivers the breathable gas in the range of 4-20 cmH₂O to a patientinterface via an air delivery conduit.

The device also includes a flow sensor to measure the flow of air alongthe conduit, and pressure sensors to measure the pressure of air at theblower outlet.

In one form, the device alternatively includes an additional pressuresensor to detect the pressure in the patient interface.

For example, FIG. 1 illustrates a ventilator device according to anexample embodiment. As illustrated, the ventilator device may include aservo-controlled blower 2, a flow sensor 4 f, pressure sensor 4 p, amask 6, and an air delivery conduit 8 for connection between the blower2 and the mask 6. Exhaust gas is vented via exhaust 13.

Mask flow may be measured by a flow sensor, such as a pneumotachographand differential pressure transducer to derive a flow signal F(t).Alternatively, the pneumotachograph may be replaced by a bundle of smalltubes aligned in parallel with the flow from the blower with thepressure difference measured by the differential pressure transduceracross the bundle.

Mask pressure is preferably measured at a pressure tap using a pressuretransducer to derive a pressure signal P_(mask)(t). The pressure sensor4 p and flow sensor 4 f have been shown only symbolically in FIG. 1since it is understood that those skilled in the art would understandhow to measure flow and pressure.

Flow F(t) and pressure P_(mask)(t) signals are sent to a controller ormicroprocessor—referred to herein as processor 15—to derive a pressurerequest signal P_(Request)(t). The controller or processor is configuredand adapted to perform the methodology described in more detail herein.The controller or processor may include integrated chips, a memory,and/or other instruction or data storage mediums to implement thecontrol methodology. For example, programmed instructions with thecontrol methodology are either coded on integrated chips in the memoryof the device, loaded as software, embedded as firmware, implemented assome combination thereof, etc. As those skilled in the art willrecognize, analogue devices may also be implemented in the controlapparatus.

The controller or processor 15 is further adapted to derive parametersindicative of the patient's breathing and sleep pattern, such as forderiving indications of flow limitation, such as flow flattening, snore,apnea and hypopnea and the Apnea Hypopnea Index (AHI), and fordistinguishing between REM and non-REM sleep. See U.S. Pat. Nos.5,704,345 and 6,029,665.

The apparatus of FIG. 1 includes other sensors, communication interfacesand displays, a servo, etc., and functional blocks the details of whichare not necessary for an understanding of the present invention.

2. Acclimatization Therapy for First Time Users

FIG. 2 illustrates an acclimatization therapy for new users of CPAPtherapy according to an example embodiment. After initial set up by aclinician, including setting of a full therapeutic pressure (step 201),the patient is sent home with a CPAP mask and blower.

2.1 Becoming Acclimatized to Headgear and/or a Mask

For the first few nights of the acclimatization therapy (e.g., two ormore nights), the patient is provided with a headgear and mask fromwhich the elbow and gas conduit have been disconnected, thus allowingthe patient to first become accustomed to the feel of the mask andheadgear during sleep, without additional impediments such as the noiseand air pressure generated by the blower (step 202). In certain exampleembodiments, noise may be introduced in addition to, or in place of,wearing the headgear. For example, a recording may be played, a blowermay be turned on with the mask left off the patient, etc.

2.2 Becoming Acclimatized to a Flow of Breathable Gas

For the next step in the acclimatization therapy, the elbow and gasconduit are connected to the mask, and the blower is turned on.

The blower is set to a “first timer mode” (also referred to herein as a“Max Ramp” or “AccliMATE” mode), in which the treatment pressure for theentire first CPAP session is provided at a sub-therapeutic pressure, forexample at 2 cmH₂O (step 203).

Before the start of the second CPAP session, a series of pre-programmedpatient and/or bed partner feedback questions are displayed on themachine display, the responses to which are used in setting thetreatment pressure for the next session. For example, the patient may beasked to provide a yes/no answer, or a rating out of ten, to questionsrelating to treatment comfort, and the patient and/or the bed partnermay be asked to respond to questions relating to patient restlessnessand sleep quality.

If the patient and/or bed partner responses are sufficiently favorableto indicate that the patient is adjusting to the sensations of thetherapy, and the recorded measurements of the treatment session indicatesubstantial patient compliance with the therapy (steps 204 and 205), thepressure for the next session is incrementally increased (step 206),e.g., by 1 cmH₂O. If the responses do not indicate patientacclimatization, or if other indicators of patient compliance for thesession are negative (for example indicating that the patient removedthe mask for a substantial period) (steps 204 and 205), the treatmentpressure is not increased (step 207), e.g., pressure unchanged.

The pressure is set for the next therapy session (step 208), and theprocess of patient feedback and incremental increase in treatmentpressure is repeated until full therapeutic pressure is reached, e.g.,after 7 or more sessions (step 209). In the case of APAP treatment, oncethe treatment pressure reaches a therapeutic pressure of 4 cmH₂O, thetreatment pressure may be a capped maximum pressure for the session. Inthe case of bilevel CPAP treatment, either just the inhalation (IPAP)pressure may be capped or both the IPAP and the exhalation (EPAP)pressure may be scaled down correspondingly. Further variations on APAPand bilevel CPAP treatment are described in more detail below.

If more than a predetermined number of successive—or cumulative—negativefeedback responses are recorded, the controller will cause display of amessage advising the patient to contact the clinician. If the device isconnected to external communication, e.g., to the telephone network, thenotification may be sent directly to the clinician e.g., data logged andclinician notified (step 210). Example processes for notifying theclinician are described in greater detail below.

Details of the patient feedback responses, and the treatment pressuresmay be stored in the controller for later review by the clinician.

In an example embodiment, the controller may be programmable by theclinician using the menu system to alter the parameters of the ‘firsttimer’ mode, for example, to set the initial therapy session pressureand/or the daily pressure increment according to the severity of thepatient's sleep disordered breathing and the clinician's opinion of howlong the patient may take to acclimatize to the sensations of the CPAPtherapy.

The acclimatization therapy thus allows the patient to gradually adjustto the sensations of CPAP therapy, with the progression profile of theacclimatization controlled according to patient feedback. It is expectedthat adoption of this approach will increase the chance of patientcompliance during the early stages of therapy, and therefore increaselong-term acceptance and compliance.

FIG. 3 illustrates a modified form of acclimatization therapy for firsttime CPAP users, which is adapted to help in setting of an appropriatemaximum treatment pressure.

In the embodiment of FIG. 3, the clinically-derived full therapeuticpressure for the patient is determined by the clinician in a titrationstudy (step 201A).

In the acclimatization therapy, the CPAP device includes a ‘Max Ramp’feature which is programmed to hold a maximum pressure for apreprogrammed day number (step S309A) and monitor the patient'srespiratory events via the device's monitoring capabilities, such as theResTraxx™ function of ResMed machines to see if that pressure is thecorrect one. Steps S302A-S307A are similar to steps 203-207, and 210 ofFIG. 2 described above. The maximum pressure is incrementally increasedeach day until a preset percentage or pressure differential from thetitrated maximum pressure is reached (step S308A), and is held there(step S315A) or increased (step S314A) based on monitored treatmenteffectiveness, the presence/absence of respiratory events, clinicianreview, or may be based upon user/bed partner feedback, comfort andcompliance (steps S310A, S311A, S312A) such as that illustrated in FIG.2. Once maximum pressure is reached (step S313A) and/or therapy sessionindicates successful treatment (step S312A), the therapeutic pressure isfixed (step S316A) and data logged and clinician notified (step S317A).

For example, a new CPAP patient may be titrated in a sleep study and amaximum treatment pressure of 12 cmH₂O may be prescribed. On the firstnight of treatment the treatment ramps from 4 to 5 cm over the first 45minutes of treatment. On the next night the pressure ramps up over 45minutes from 5 cm to 6 cm and so on until it gets to within apredetermined amount—for example 4 cmH₂O—or a predeterminedpercentage—such as 80%—of the prescribed maximum treatment pressure. Soin this example the CPAP machine may be programmed by the clinician tostop the daily increase at a pressure of 8 (i.e., 12-4) cmH₂O for a setnumber of days (e.g., up to 7 days) to monitor the patient airway usingthe monitoring functions of the CPAP machine. If the patient is nothaving adverse respiratory events at, for example, the pressure of 10cm, then the maximum treatment pressure may be fixed at that levelrather than progressing to the originally-prescribed level of 12. If thepatient is still having adverse respiratory events at a pressure of 12,then the machine may increase it or refer the patient to the clinicianfor a decision on whether to increase the treatment pressure.

It is envisaged that this acclimatization therapy would give at leastsome of the benefits of the AutoSetting function of an AutoSet CPAPmachine but would result in a fixed pressure that manyDoctors/Clinicians are comfortable with rather than AutoSettingadjustment of the treatment pressure breath-by-breath. This keepsgreater control of the set pressure in the hands of the clinician, whichsome patients and clinicians may be more comfortable with. Thisacclimatization may also be used as a stepping stone to getting patientsand clinicians accustomed to AutoSetting functions.

In addition to the above techniques which may be used to help patientsusing CPAP devices prepare for treatment via AutoSet devices, AutoSetdevices themselves may be configured to provide acclimatization therapyto a patient. For example, in certain example embodiments, in an AutoSetdevice, a first minimum pressure level may be initially provided. Theminimum pressure level may be increased over time, for example, asdefined in other parts of this disclosure. Alternatively, or inaddition, the level of gain in pressure in response to an event mayincrease over time. For example, when an apnea is detected, a firstpressure may be provided to treat it. For subsequent apneas (e.g. apneas2 and 3), the pressure may be increased a predetermined amount. Apneasafter these (e.g. apneas 4 and 5) may be treated with a pressure boostgreater than the first predetermined amount. In particular, a firstapnea (or a first group of apneas) may be treated by increasing thepressure 0.5 cmH₂O/minute, whereas a second apnea (or a second group ofapneas) may be treated by increasing the pressure 1 cmH₂O/minute.

FIG. 4 helps to illustrate several possibilities that may arise whensuch example embodiments are implemented. FIG. 4 is an illustrativepressure vs. time graph for acclimatization therapy with an AutoSetdevice in accordance with an example embodiment. In FIG. 4, the AutoSetdevice provides a supply of breathable gas at a minimum pressure P₁ fromtime t₀ to t₁. The minimum pressure is increased a predetermined amountto pressure P₂ from time t₁ to t₂. The minimum pressure again isincreased a predetermined amount to pressure P₃ from time t₂ to t₃. Attime t₃, an apnea is detected. Accordingly, the pressure is boosted apredetermined amount to P₄. When the apnea is normalized at time t₄, thepressure drops to its previous minimum level, P₃. Another apnea event isdetected at time period t₅, and the pressure is boosted to P₅. Theamount of the pressure boost from p₄ to p₅ is greater than the amount ofthe pressure boost was from P₃ to P₄. For example, P₅=(P₄−P₃)+δ, where δis a incremental change in the gain provided during an obstructiveevent. When the apnea is normalized at time t₆, the pressure reduces toa new minimum pressure level, P₆.

2.3 Increased Clinician Control Over Treatment and Treatment Parameters

In the flowchart of FIG. 3, those items in bold may be preset orprescribed by the clinician (e.g., initial sub-therapeutic pressure,increment pressure, max pressure, pre-limit or % of max pressure, X no.of days to hold at pre-limit or % of max pressure, no. of events orother criteria that indicates successful treatment). Those boxes indashed lines may optionally be omitted.

Possible advantages of the acclimatization therapy of FIG. 3 includeimprovement in the treatment of patients where the prescribed pressureis too high or too low, with consequent reduction in therapist's timetreating those patients. Such patients currently take a substantialamount of therapist's time for treatment because they are being overtreated or under treated and furthermore these patients are often nothappy/compliant. The stair stepping approach of the ‘Max Ramp’ featurecould cut the costs of treatment of such patient by helping todetermining the appropriate pressure with minimal therapistintervention. The method may be carried out with modifications based ona ResMed Elite machine or a ResMed ResTraxx machine, both of which areless expensive machines than one having full AutoSet capabilities. Ifthe prescribed pressure was determined to be wrong, the home medicalequipment (HME) provider could send the patient a card to change thepressure; simple and cost effective. Also, the method includes minimalwork from the patient, which helps to achieve new patient compliance andacceptance of the treatment.

A further embodiment of the invention provides a simplifiedacclimatization therapy (“Max ramp”) mode with greater control by theclinician.

In this embodiment, the machine is programmable to increase the maximumtreatment pressure automatically over time. The Clinician could programthe start pressure, for example, 4 cm, and have the device ramp up tothe prescribed pressure over a set period of time with no patientinvolvement.

For example, start pressure may be set at 4 cmH₂O and maximum pressureset at 10 cmH₂O. The clinician could prescribe a Max Ramp of 6 days. OnDay 1 the device would start at 4 cmH₂O and stay at 4 cmH₂O all night.On day 2 the device would start at 4 cmH₂O and ramp, depending on theset ramp time (max 1 hour), to 5 cmH₂O and stop. Day 3 start at 4 cmH₂Oand ramp to 6 cmH₂O, and so on, until the set maximum therapeuticpressure is reached.

The clinician would choose the number of days the Max ramp was to occurand the device would calculate the daily increase in a linear or otherpredetermined fashion. Alternatively the clinician could set the startpressure and start Max Ramp feature. For example, start pressure 4 cmH₂Oand stop at the start Max Ramp Feature of 7 cmH₂O, max pressure=12cmH₂O.In this scenario, day one the device would start at 4 cmH₂O, ramp to 7cmH₂O over the ramp time (max 1 hour) then hold there for the firstnight. On day 2 the device would start at 4 cmH₂O, ramp (max 1 hour) to8 cmH₂O (or what ever the linear calculation says, and stop) and so onthroughout the set time for the Max Ramp.

2.3 Compliance Monitoring and Treatment Adjustment

Optionally, the clinician could choose a machine mode which allows thepatient to hold at a pressure for an additional night if the patientfeels the pressure is becoming too much. This could be accomplished bypressing a sequence of buttons on the device. This machine mode alsoallows programming by the clinician to set boundary conditions on theacclimatization therapy (“Max ramp”) mode.

For example, the machine display may prompt the patient at the end ofeach daily session to enter a response indicating how they coped withthe therapy. The patient could press “Okay” or “Not okay”. If manysubsequent days are “okay”, the machine increases the daily rampincrement to ramp to prescribed maximum therapy pressure moreaggressively, thus bringing the patient to therapy as early as possible.If the patient responses indicate that the patient is struggling toacclimatize to therapy (e.g. two consecutive days of “Not Okay”), thedaily ramp increment is decreased to extend the acclimatization period,within the clinician-set boundaries.

More than a preset number of daily “Not okays” may cause the device toprompt the patient with help details (visual and/or audible methods)and/or request patient to contact clinician before getting toofrustrated with the therapy, thus potentially reducing drop-outs evenfurther.

Alternatively, or in addition to gathering such information, certainexample embodiments may include a compliance monitoring package. Thiscompliance monitoring package may monitor one or more parametersassociated with a patient's comfort level and/or compliance level withrespect to the device. For example, monitored parameters may includechanges in the patient's Apnea-Hypopnea Index (AHI), changes in the leaklevel, the number of “mask off” events, etc. As noted above, the devicemay accordingly provide assistance in overcoming potential problems, orsuggest calling the physician (e.g. by displaying such information tothe patient, etc.). In one example embodiment, once compliance data hasbeen captured, diagnoses may be made by the compliance monitoringpackage by comparing any compliance data to identifiable problems orpreprogrammed problem heuristics (e.g. repeated mask off events maycorrespond to a poor fit, a very restless sleeper, etc.). If problemsare identified, a database of suggested solutions may be referenced. Theappropriate solutions may then be displayed, or, if no solutions exist,the compliance monitoring package may suggest a visit to the sleep lab.It will be appreciated that the compliance monitoring package mayinclude hardware, software, firmware, and/or a combination thereof. Forexample, a hardware sensor may be required to measure leak, whilesoftware may compute the patient's AHI. As another example, thecompliance monitoring package may be embodied in a series ofinstructions included in the processor or controller of a flowgenerator. However, it will be appreciated that such configurations arepresented by way of example and without limitation. It also will beappreciated that such compliance monitoring packages may be used withother acclimatization techniques, such as, for example, those describedherein. As a further example, a compliance monitoring package may beconfigured to work with the techniques described below with reference toFIG. 4A, such that acclimatization therapy may be provided (steps S402,S404, S406, and S407), and a patient may alone or with a physician usethe illustrative compliance monitoring package described herein fordiagnosis and further treatment. Thus, step S408 may communicate theinformation to a physician and/or the compliance monitoring package, andthe adjustments of step S410 may be applied by the physician and/or thepatient in response to output generated by the monitoring package.

Where the device has communication capabilities, the device may alsocontact the clinician directly to get into contact with the patient. Forexample, a commercially available system such as ResTraxx™ may allow aclinician at a remote location to monitor and/or alter the patient'stherapy. It will be appreciated that such remote monitoring may beperformed automatically (e.g. reports may be sent periodically, whenproblems are detected, etc.), or it may allow a clinician to choose whento retrieve data via one or more communicators.

In particular, FIG. 4A is a flowchart illustrating a process forremotely controlling acclimatization therapy, in accordance with anexample embodiment. In step S402, at least one parameter of the patientis observed to determine an appropriate full treatment pressure. In stepS404, a limited treatment pressure less than the full treatment pressureis set. Then, in step S406, breathable gas is provided to the patient atthe limited treatment pressure. Parameters corresponding to patient'sacceptance of the treatment are monitored in step S407 and communicatedto a sleep clinician remote from the patient in step S408. Optionally,in step S410, the limited treatment pressure may be adjusted based on asignal from the remote sleep clinician.

Other techniques may be used to allow clinicians to alter treatmentparameters and/or store data relating to the treatment (e.g. informationrelating to how well a patient is acclimatizing to a treatment, theextent to which the treatment is successful, etc.). According to anexample embodiment, a treatment device may be configured to read dataembedded on one or more smartcards. Each smartcard may have a set oftreatment parameters embedded thereon, and thus, different smartcardsmay be appropriate for different conditions. For example, one series ofsmartcards may be appropriate for treating snore, and another series maybe appropriate for treating apneas. It will be appreciated that otherconfigurations also are possible, and the examples are provided fornon-limiting, illustrative purposes.

With regard to acclimatization in particular, a series of smartcardsmay, for example, be programmed to provide increasing breathing gaspressures. Thus, as a patient replaces cards, the pressures may bestepped up. In certain example embodiments, the smartcards may functiononly for a predetermined period (e.g. one night, one week, etc.) or apredetermined number of uses (e.g. once, twice, etc.). Thus, thesmartcards may, for example, prevent a patient from reverting to lowerpressures (e.g. pressures that the patient may have already becomeacclimatized to and thus confer little or no therapeutic advantage),thus progressing the acclimatization. It also may help ensure thatpatients receive follow-up diagnoses as a specific sleep study or courseof treatment concludes, etc.

It will be appreciated that the smartcards also may storetreatment-related data, as monitored by the device, inputted by thepatient, etc. This data may be retrieved by a clinician, for example, totrack a patient's acclimatization and/or treatment progress, reviseprescribed therapies, etc.

FIG. 5 is an illustrative view of a memory map embedded in a smartcardin accordance with an example embodiment. Duration data is stored inarea 502. Duration data may include information, such as, for example,the number of times certain settings may be used, a time period duringwhich the smartcard is operable, etc. Area 504 indicates a pressure atwhich the therapy should begin, while area 506 indicates a target or endpressure that the therapy should reach. Area 508 includes ramp up data(e.g. how long a ramp up period should last, how fast the pressureshould ramp up, etc.). Area 510 indicates how long the patient's sleepshould last (e.g. 8 hours, etc.). It will be appreciated that other datamay be embedded in the smartcard in place of, or in addition to, thedata shown. It also will be appreciated that certain areas of the datamay be writeable to store parameters (e.g. acclimatization data, numberof uses, etc.).

3. Further Variations on Acclimatization Therapy Techniques

3.1 Treatment During Awake Settling Times

According to an example embodiment, a first pressure (or first set ofpressures) may be provided in the period during which the patient isfalling asleep, and a second pressure (or second set of pressures) maybe provided while the patient is asleep. This or similar techniques maybe used as an alternative to certain other example embodiments which, asdescribed above, may deliver sub-therapeutic pressures throughout thenight and ramp up pressures over a number of nights, which therebydelays the time until the full pressure is delivered until a later pointduring the therapy.

More particularly, a low pressure level may be delivered during an awakesettling time. This low pressure level may be delivered for apredetermined amount of time (e.g. fifteen minutes, thirty minutes, onehour, etc.). Thus, the patient may become acclimatized to receiving atleast some pressurized gas before the full therapeutic level isdelivered during the course of the night. Following this predeterminedtime limit, the device may ramp up to the full therapeutic pressure.Optionally, the length of time of the ramp up during the sleep phase maybe selected. According to an example embodiment, the initial pressuredelivered during the settling time may ramp up over several days, forexample, reducing the amount of time a patient before the full treatmentpressure is delivered.

FIG. 6A is an illustrative flowchart in which different pressures areprovided for the period in which a patient is falling asleep and theperiod in which the patient is asleep. In step S602, a first pressure orfirst set of pressures is/are delivered for a predetermined time period.This first time period corresponds to treatment while the patient isfalling asleep, and there may be a ramp up during this period. In stepS604, a second pressure or second set of pressures is/are deliveredwhile the patient is asleep. Again, the pressures may ramp up at thistime.

The predetermined time limit may reflect the amount of time it takes forthe patient to fall asleep. In an example embodiment, the device maycomprise a “snooze button” to allow the patient to prolong the awakesettling period by an additional predetermined amount of time (e.g. 10minutes, 15 minutes, 30 minutes, etc.). It will be appreciated that the“snooze feature” relates to the comparative inactivity of the device,rather than the state of the patient. Alternatively, the snooze featuremay be thought of as providing an additional amount of time needed toallow the patient to begin “snoozing.” Thus, the patient may extend thedelay before the ramp up period begins if the patient does not fallasleep during the initial predetermined time. In certain exampleembodiments, a device may store how many times a patient pushes thesnooze button. Based on this data, the device may “learn” how long ittakes a patient to fall asleep and adjust the initial predetermined timeamount accordingly. Thus, in response to this “preferred settling time,”the device may adjust an initial ramp up period (e.g. during thesettling time) or the ramp up period during sleep accordingly.Similarly, as the patient acclimatizes to the therapy, the awakesettling time may be reduced based on the recorded data. It will beappreciated that this technique may be used as a further refinement tocertain example techniques described below which, in general, monitorthe patient's sleep state and change the delivered pressure based on thesleep stage, possibly including whether the patient is asleep at all(e.g. one or more parameters for determining whether the patient isasleep may be monitored). Alternatively, it will be appreciated thatthis technique may be conceived of as a sub-classification of thebelow-described techniques. For example, illustrative sleep stages mayinclude, for example, awake, falling asleep, REM sleep, NREM sleep, etc.

FIG. 6B is an illustrative flowchart in which different pressures areprovided for the period in which a patient is falling asleep and theperiod in which the patient is asleep, taking into account a mechanismfor delaying transition to the sleep period mode. Again, in step-S606, afirst pressure or first set of pressures is/are delivered for apredetermined time period. This first time period corresponds totreatment while the patient is falling asleep, and there may be a rampup during this period. If the snooze button is hit in step S608, stepS610 continues to deliver the first pressure or first set of pressuresfor a predetermined duration. If the snooze button is not hit in stepS608, in step S612 a second pressure or second set of pressures is/aredelivered while the patient is asleep. Again, the pressures may ramp upat this time.

3.2 Treatment According to Sleep Stage

Similar to delivering different pressures (or different sets ofpressures) based on whether a patient is asleep, certain exampleembodiments may deliver different pressures based on sleep stage. Thus,a device may first determine the sleep stage a patient is in. Based onthis determination, a suitable pressure may be delivered. For example,higher treatment pressures may be delivered during REM sleep as comparedto NREM sleep (e.g. because REM sleep typically is characterized by arelatively considerable amount of body activity, whereas NREM sleeptypically is characterized by progressive relaxation). Treatmentparameters for each of the different stages of sleep may be preset byclinicians. Thus, the patient may receive therapeutic pressures at thesleep stages in which they are needed most. For example, the patient maynot receive high pressures while they are awake (e.g. before fallingasleep, while waking up after REM sleep, etc.). In such cases, thedevice may detect arousals and adjust the pressure accordingly.

FIG. 7 is an illustrative flowchart showing a process for providing aset of pressures based on the patient's sleep stage in accordance withan example embodiment. The sleep stage the patient is in is determinedin step S702. In step S704, a set of pressures is provided based on thesleep stage determined in step S702. If it is determined that the sleepchange has not changed in step S706, the pressure levels are notchanged. If the sleep state is changed, it is determined whether thepatient is awake in step S708. If the patient is awake, the process isover. In this case, the supply of breathable gas may be stoppedcompletely, reduced to a comfortable “awake pressure,” etc. If thepatient awakens briefly, the process may return to step S702 when thepatient falls asleep again. However, if the patient is not awake, theprocess returns to step S702 to determine the new sleep stage and toprovide an appropriate pressure in step S704. It will be appreciatedthat a treatment pressure may be provided initially at a limitedpressure and then ramped up to a full treatment pressure associated withthe particular sleep stage.

3.3 Using Bilevel Treatments to Acclimatize a Patient to Full CPAPTreatment

Regardless of the whether the patient is asleep and the type of sleepthe patient is in, as noted above, some patients may not respond well tosingle-level CPAP therapy. An example acclimatization process mayaccordingly first provide bilevel therapy and transition to CPAP mode asthe patient becomes acclimatized to the therapy. This process reflectsthe reality that some patients respond well to increased pressuresduring inhalation, but respond poorly during exhalation. Thus, a devicemay begin in bilevel mode, providing IPAP and EPAP therapies at distinctpressures. As the patient becomes more acclimatized to EPAP therapy, thepressure may be ramped up. When IPAP and EPAP parameters aresubstantially the same, CPAP therapy effectively will be administered.In certain example embodiments, the IPAP therapy may remain constant asthe EPAP therapy is ramped up. Alternatively, IPAP and EPAP therapiesboth may be ramped up, but with IPAP and EPAP parameters being adjustedat different rates. For example, the IPAP may reach the target CPAPlevel more quickly because inhalation pressure may be accepted moreeasily. In cases where the IPAP and EPAP parameters are substantiallythe same but are nonetheless lower than the target CPAP parameters, theymay be adjusted together or apart, depending, for example, on theparticular patient, the acclimatization history, etc.

FIG. 8 is an illustrative flowchart showing how a bilevel device can bemade to provided CPAP therapy as a part of acclimatization therapy. InFIG. 8, the target CPAP parameters (e.g. a pressure of breathable gas,etc.) is identified. A bilevel treatment below the target CPAP level isprovided in step S804, with the treatment level potentially being basedin part on sleep stage. IPAP and/or EPAP may be ramped up according toan acclimatization rule in step S806. For example, IPAP pressures mayramp up faster than EPAP pressures, but it may also reach a plateau morequickly than the EPAP therapy. Step S808 determines whether the deviceis functioning at the target CPAP level. If it is not, the bileveltreatment continues in step S804, and ramp ups may occur in step S806.If the target CPAP levels have been reached, the process is ended.

3.4 Example Software Modes and Settings

Further details of the process phases, the machine modes and an exampleof this embodiment are set out below.

A. Acclimatization Process Phases:

The acclimatization therapy goes through three phases:

-   -   1. Initiation Phase: Physician or Clinician prescribes an        “AccliMATE” mode    -   2. AccliMATE Phase: the AccliMATE mode automatically adjusts        nightly CPAP pressure until final set-point CPAP pressure is        reached according to physician or clinician    -   3. Standard CPAP Phase: Flow Generator Operates in Standard CPAP        mode

B. AccliMATE Mode Detail:

1. Physician/Clinician Adjustable Parameters:

-   -   (a) Adjustment period (settable range): 1-30 days    -   (b) End target CPAP setting (“T”): 4-20 cm H2O    -   (c) Starting night #1 CPAP setting (“S”): 4-* H2O (can only be        set where “S”<“T”)    -   (d) Optional patient “snooze” button function. When pressed by        the patient this would maintain previous day's CPAP pressure        setting for a physician/clinical set limited number of days at        any individual pressure. Settable range=0-5 days. This snooze        function can be turned off or can allow the patient to remain at        any one pressure for a limited number of days if they push the        “snooze’ button at the beginning of the next night's session        during the CPAP AccliMATE phase.        Note: standard nightly ramp from 4 cm H₂O to that night's set        point can be set as normal from 0-45 minutes using standard ramp        function

2. Machine calculation modes:

-   -   (a) Linear    -   (b) Logarithmic    -   (c) Exponential    -   (d) Step-function (0.5 cm/day, 1 cm/day, 2 cm/day, 3 cm/day,        etc.)    -   (e) Other formulae

C. Example:

Clinician/Physician sets:

-   -   (a) Adjustment period=7 days    -   (b) End target CPAP=10 cm H2O    -   (c) Starting CPAP=4 cm H2O    -   (d) Patient Snooze=0 days (i.e., off)

Day # 1 2 3 4 5 6 7 CPAP 4 cmH₂O 5 cmH₂O 6 cmH₂O 7 cmH₂O 8 cmH₂O 9 cmH₂O10 cmH₂O

In an alternative embodiment, a continuous ramp may be used throughoutthe entire acclimatization period rather than using incremental rampsessions (e.g., up to 1 hour) to increase the pressure and thenmaintaining a lower pressure level for the remainder of the therapysession.

For example, the clinician may set the start pressure at 4 cmH₂O and thefinal treatment pressure of 12 cmH₂O with a MAX Ramp of 5 days. Thedevice would continuously increase the pressure throughout the 5-dayperiod. The machine would calculate the required rate of increase basedon a predetermined formula. Alternatively, the clinician may set therate of increase instead of the number of days for the MAX Ramp:

In an example, on day 1, start CPAP pressure (P1) would be 4 cmH₂O andthe end CPAP pressure would be P2 wherein P2 is >4 cmH₂O but <12 cmH₂Odepending on the time of use of the first night. On day 2, the startCPAP pressure would be P2 and the end CPAP pressure would be P3. On day3, the start CPAP pressure would be P3 and the end CPAP pressure wouldbe P4, and so on until pressure reaches the final treatment pressure,e.g., 12 cmH₂O.

In another embodiment, therapy may be started at full therapeuticpressure, and then after identifying a problem indicating that thepatient is not coping at that pressure, decreasing the pressure to alower level for a predetermined amount of time. The patient may identifya problem by inputting this into the device or the device may detectwhen a patient is having trouble with therapy and adjusting tocompensate. For example, the device may measure the number of mask offevents over time or the level of leak. In an embodiment, the initialstart pressure of the therapy is determined based on inputs from thepatient. The patient may provide an indication of how they cope with newthings. The pressure would progressively increase back up to therapeuticpressure.

In yet another embodiment, the slow ramp or Acclimate mode may becontrolled by the patient in that the patient may choose to eitherincrease the pressure by a single increment upon commencing each newtherapy session (or after each predetermined time period) or goingdirectly to full therapeutic pressure. Thus, the increment is notautomatic. A default back to full therapeutic pressure would preventpatients from continuing using the device sub-therapeutically for toolong. In an embodiment, the device may learn the patients preference(e.g., increase every night or only every second night) and take overincreasing the therapy pressure.

Each of the above described embodiments describes various alternativemethods to assist in acclimatizing a patient to therapy or makingtherapy more comfortable for first time users. This boosts patientcompliance and long term therapy.

Methods may include automatic methods where the device controls theentire process, semi-automatic methods where the patient interacts withthe device to cause the machine to change parameters, and mechanicalmethods where the parameters are changed via a mechanical means ratherthan software.

3.5 Mechanical Methods for Changing Delivered Pressure Levels

In certain example embodiments, the pressure may be adjusted toacclimatize the patient to therapy by using the flow generator tocontrol the pressure delivered. However, certain example embodimentsprovide user-controlled, mechanical processes for adjusting the pressureduring patient acclimatization by, for example, controlling the level ofleak in the patient circuit. Conventionally, mask leak is thought of asbeing disadvantageous, or, at a minimum, a factor that must be accountedfor when administering a treatment. However, as a part of theacclimatization process, controlling the level of leak in the patientcircuit may alter the delivered therapy level.

Thus, a vent or opening may be located on a mask to purposely allow forsome leak. Then, the vent or opening may be progressively closed. As theopening becomes smaller, the leak will decrease and the deliveredpressure will increase accordingly. By carefully choosing the size ofthe openings, it will be appreciated that the amount of leak may bereduced (and thus the delivered pressure may be increased) according toa scale (e.g. a linear scale, an exponential scale, etc.).

In certain example embodiments, it may be advantageous to allow the ventto be adjusted in one direction only, thus preventing a patient fromreverting to a lower pressure level and thereby potentially slowing (orreversing) the acclimatization process. In certain example embodiments,a dial having protrusions capable of engaging with pre-formed recessionsmay be rotated to provide this form of mechanical leak control system.However, it will be appreciated that other suitable mechanicalmodifications may be made to a mask, and that the rotating dial isprovided by way of example and without limitation. One mask system thatmay be used with these techniques is disclosed in U.S. application Ser.No. 10/579,221, entitled “Vent System for CPAP Patient Interface Used inTreatment of Sleep Disordered Breathing,” filed May 12, 2006 andassigned to ResMed, which is a national stage application of PCTAU/04/01650 filed on Nov. 25, 2004, the entire contents of each of whichis incorporated herein by reference.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise, comprised and comprises” where they appear.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each aspect, feature, or step ofany example embodiment alone may constitute an additional embodiment ofthe present invention. In addition, while the invention has particularapplication to patients who suffer from OSA, it is to be appreciatedthat patients who suffer from other illnesses (e.g., congestive heartfailure, diabetes, morbid obesity, stroke, barriatric surgery, etc.) canderive benefit from the above teachings. Moreover, the above teachingshave applicability with patients and non-patients alike in non-medicalapplications.

1. A method of acclimatizing a patient to CPAP therapy for treatment ofsleep-disordered breathing, the method comprising: providing a deviceconfigured to supply pressurized breathable gas to the patient; and,providing at least one smartcard, each smartcard having treatmentparameters stored thereon; wherein the device is configured to acceptthe at least one smartcard and to provide the supply of pressurizedbreathable gas based on the treatment parameters stored thereon.
 2. Themethod of claim 1, further comprising programming the smartcard with apressure setting, the device being operable to supply the breathable gasat the pressure setting.
 3. The method of claim 1, further comprisingprogramming the smartcard with a limited pressure setting, a fulltherapeutic pressure setting greater than the limited pressure setting,and/or ramp up information, the ramp up information including the rateat and/or time period over which the device should adjust the pressureof the breathable gas from the limited pressure setting to the fulltreatment pressure setting.
 4. The method of claim 1, further comprisingprogramming the smartcard with duration data, the duration dataindicating a time and/or a predetermined number of uses after which thesmartcard becomes inactive, the device being operable to supply thebreathable gas in dependence on the duration data.
 5. The method ofclaim 1, further comprising programming at least two smartcards, eachsmartcard being programmed with different sets of treatment parameters.6. The method of claim 5, further comprising using the at least twosmartcards in a predetermined order.
 7. The method of claim 1, furthercomprising storing patient compliance data from the device on thesmartcard.
 8. The method of claim 7, further comprising providing thesupply of breathable gas further based on the patient compliance data.9. A CPAP device for acclimatizing a patient to treatment ofsleep-disordered breathing, the CPAP device being operable to provide asupply pressurized breathable gas to the patient based on treatmentparameters stored on a smartcard, the smartcard being readable by theCPAP device.
 10. The CPAP device of claim 9, wherein the smartcardcomprises a pressure setting, the device being operable to supply thebreathable gas at the pressure setting.
 11. The CPAP device of claim 9,wherein the treatment parameters comprise a limited pressure setting, afull treatment pressure setting greater than the limited pressuresetting, and/or ramp up information, the ramp up information includingthe rate at and/or time period over which the device should adjust thepressure of the breathable gas from the limited pressure setting to thefull treatment pressure setting.
 12. The CPAP device of claim 9, whereinthe device is configured to provide the supply of pressurized breathablegas further based on duration data stored on the smartcard, the durationdata indicating a time and/or a predetermined number of uses after whichthe smartcard becomes inactive.
 13. The CPAP device of claim 9, whereinat least two smartcards are provided, each smartcard having a differentset of treatment parameters stored thereon.
 14. The CPAP device of claim13, wherein the at least two smartcards are configured to be used in apredetermined order.
 15. The CPAP device of claim 9, wherein the deviceis configured to store patient compliance data on the smartcard.
 16. TheCPAP device of claim 15, wherein the device is configured to provide thesupply of breathable gas further based on the patient compliance data.17. A smartcard for use with a device operable to provide a supply ofpressurized breathable gas to a patient, the smartcard having treatmentparameters stored thereon, the treatment parameters comprising apressure setting to be supplied to the device.
 18. The smartcard ofclaim 17, wherein the treatment parameters comprise a limited pressuresetting, a full treatment pressure setting greater than the limitedpressure setting, and/or ramp up information, the ramp up informationincluding the rate at and/or time period over which the device shouldadjust the pressure of the breathable gas from the limited pressuresetting to the full treatment pressure setting.
 19. The smartcard ofclaim 17, further comprising duration data, the duration data indicatinga time and/or a predetermined number of uses after which the smartcardbecomes inactive.
 20. A method of acclimatizing a patient to CPAPtherapy for treatment of sleep-disordered breathing, the methodcomprising: providing a device configured to supply pressurizedbreathable gas to the patient; identifying target CPAP treatmentparameters to be used when treating the patient, the target CPAPtreatment parameters comprising a full treatment pressure to bedelivered to the patient during patient inspiration and patientexpiration; providing a bilevel treatment, the bilevel treatmentcomprising providing IPAP therapy and/or EPAP therapy; ramping upparameters associated with the IPAP therapy and/or parameters associatedwith the EPAP therapy until the target CPAP treatment parameters aremet.
 21. The method of claim 20, further comprising independentlyramping up the parameters associated with the IPAP therapy and theparameters associated with the EPAP therapy.
 22. The method of claim 20,further comprising setting the IPAP therapy to a pressure higher thanthe EPAP therapy.
 23. A PAP device for acclimatizing a patient totreatment of sleep-disordered breathing, comprising: a flow generatoroperable in acclimatization and CPAP modes to provide a supply ofpressurized breathable gas to the patient; a controller operable toinstruct the flow generator, in the acclimatization mode, to provide thebreathable gas at a first pressure during patient inspiration, and toprovide the breathable gas at a second pressure during patientexpiration, the second pressure being different from the first pressure;wherein the controller is operable to adjust the first pressure and/orthe second pressure until a target CPAP therapy is provided at whichpoint the flow generator operates in the CPAP mode, the target CPAPtherapy having a full treatment pressure to be delivered to the patientduring patient inspiration and patient expiration associated therewith.24. The PAP device of claim 23, wherein the controller is configured toadjust the first pressure and the second pressure independently.
 25. ThePAP device of claim 23, wherein the first pressure is higher than thesecond pressure during an initial portion in the acclimatization mode.26. A method of acclimatizing a patient to therapy for treatment ofsleep-disordered breathing, the method comprising: continuouslymonitoring at least one parameter of the patient; associating the atleast one parameter with a continuously adjusting treatment pressure forthe patient; and, providing a supply of pressurized breathable gas tothe patient at a continuously adjusting pressure based on the at leastone parameter; wherein the breathable gas initially is provided at anadjustable limited pressure, the limited pressure being below thetreatment pressure, and further wherein the limited pressure is rampedup during the treatment until the limited pressure equals the treatmentpressure.
 27. A PAP device for acclimatizing a patient to treatment ofsleep-disordered breathing, comprising: a monitor operable tocontinuously monitor at least one parameter of the patient; a processoroperable to associate the at least one parameter with a continuouslyadjusting treatment pressure; and a flow generator operable to provide asupply of pressurized breathable gas to the patient at a continuouslyadjusting pressure based on the at least one parameter; wherein the flowgenerator is configured to provide the breathable gas at the treatmentpressure and at a limited pressure, the limited pressure being below thetreatment pressure, and further wherein the flow generator is operableto ramp up the limited pressure until the limited pressure equals thetreatment pressure.
 28. A method of acclimatizing a patient to therapyfor treatment of sleep-disordered breathing, the method comprising:monitoring at least one parameter of the patient; associating the atleast one parameter with a treatment pressure for the patient; providinga supply of pressurized breathable gas at the treatment pressure to thepatient; detecting one or more obstructive events during the treatment;and, for each obstructive event detected, incrementally increasing thetreatment pressure a predetermined amount.
 29. The method of claim 28,wherein the obstructive event is an apnea.
 30. The method of claim 28,wherein the treatment pressure is variably incremented for eachobstructive event detected.
 31. The method of claim 28, wherein thetreatment pressure is incrementally increased by 0.5 cmH₂O for eachobstructive event detected.
 32. A PAP device for acclimatizing a patientto treatment of sleep-disordered breathing, comprising: a monitoroperable to monitor at least one parameter of the patient and operableto detect one or more obstructive events during treatment; a processoroperable to associate the at least one parameter with a treatmentpressure; and a flow generator operable to provide a supply ofpressurized breathable gas to the patient; wherein the flow generator isconfigured to incrementally increase the treatment pressure apredetermined amount for each obstructive event detected by the monitor.33. The PAP device of claim 32, wherein the obstructive event is anapnea.
 34. The PAP device of claim 32, wherein the treatment pressure isincrementally increased by 0.5 cmH₂O for each obstructive eventdetected.
 35. The PAP device of claim 32, wherein the treatment pressureis variably incremented for each obstructive event detected.
 36. Amethod of acclimatizing a patient to therapy for treatment ofsleep-disordered breathing, the method comprising: observing the patientto determine a full treatment pressure appropriate for the patient;determining a limited treatment pressure less than the full treatmentpressure; providing a supply of pressurized breathable gas to thepatient at the limited treatment pressure; monitoring at least oneparameter of the patient, the at least one parameter corresponding topatient acceptance of the treatment; and, communicating the at least oneparameter to a sleep clinician via a computer-mediated communicationchannel, the sleep clinician being located remote from the patient. 37.The method of claim 36, further comprising adjusting the limitedtreatment pressure based on a determination made by the sleep clinician,the adjustment being made from the location remote from the patient. 38.The method of claim 36, wherein the limited treatment pressure isincreased to a pressure less than or equal to the full treatmentpressure.
 39. A system for acclimatizing a patient to therapy fortreatment of sleep-disordered breathing, comprising: a flow generatoroperable to provide a supply of pressurized breathable gas to thepatient at a plurality of pressures; a sensor operable to monitor atleast one parameter of the patient; and, a first communicator operableto send the at least one parameter to a sleep clinician, and furtheroperable to receive at least one treatment parameter from the sleepclinician; wherein the sleep clinician is located remote from thepatient, and wherein the pressure of the breathable gas initially isprovided at a limited treatment pressure less than a full treatmentpressure appropriate for the patient.
 40. The system of claim 39,wherein the pressure of the breathable gas optionally is adjusted basedon the treatment parameter received from the sleep clinician.
 41. Thesystem of claim 39, wherein the flow generator is configured to increasethe limited treatment pressure to a pressure less than or equal to thefull treatment pressure.
 42. A method of acclimatizing a patient totherapy for treatment of sleep-disordered breathing, the methodcomprising: providing a supply of pressurized breathable gas through atube to a mask, the mask having an opening therein, the opening allowingcontrolled mask leak; and, adjusting a size of the opening to alter anamount of mask leak and cause a corresponding change in the breathablegas pressure; wherein the size of the opening is adjusted to vary apressure of the breathable gas between a full treatment pressure and alimited pressure, the limited pressure being less than the fulltreatment pressure.
 43. The method of claim 42, further comprisingpreventing the size of the opening from being subsequently increased.44. A mask for use by a patient during therapy for treatment ofsleep-disordered breathing, the mask being configured to receive asupply of pressurized breathable gas from a tube connected to a flowgenerator, comprising: an opening, the opening allowing controlled maskleak; and, an adjustment mechanism for adjusting a size of the openingto alter an amount of mask leak and for causing a corresponding changein the breathable gas pressure; wherein the size of the opening isconfigured to be adjusted to vary a pressure of the breathable gasbetween a full treatment pressure and a limited pressure, the limitedpressure being less than the full treatment pressure.
 45. The mask ofclaim 44, wherein the opening comprises one or more vent holes.
 46. Themask of claim 44, wherein the adjustment mechanism prevents the size ofthe opening from being increased.
 47. A system for acclimatizing apatient to therapy for treatment of sleep-disordered breathing,comprising: a flow generator operable to provide a supply of pressurizedbreathable gas to the patient through a flexible tube connected to amask; wherein the mask comprises: an opening, the opening allowingcontrolled mask leak; and, an adjustment mechanism for adjusting a sizeof the opening to alter an amount of mask leak and for causing acorresponding change in the breathable gas pressure; wherein the size ofthe opening is configured to be adjusted to vary a pressure of thebreathable gas between a full treatment pressure and a limited pressure,the limited pressure being less than the full treatment pressure. 48.The system of claim 47, wherein the adjustment mechanism prevents thesize of the opening from being increased.
 49. A method of acclimatizinga patient to therapy for treatment of sleep-disordered breathing, themethod comprising: identifying a plurality of full treatment pressures,each full treatment pressure being associated with a sleep stage;determining the sleep stage of the patient; and, providing a supply ofpressurized breathable gas to the patient in dependence on the sleepstage of the patient.
 50. The method of claim 49, wherein a firstpressure provided to the patient during a comparatively active sleepstage is lower than a second pressure provided to the patient during acomparatively inactive sleep state.
 51. The method of claim 50, whereinthe comparatively active sleep stage is REM sleep, and the comparativelyinactive sleep stage is NREM sleep.
 52. The method of claim 49, furthercomprising for each sleep stage, providing the breathable gas at alimited pressure lower than a full treatment pressure; and, ramping upthe pressure of the breathable gas from the limited pressure to the fulltreatment pressure.
 53. The method of claim 49, wherein the supply ofbreathable gas is provided at a low pressure when the patient is awake.54. A PAP device for acclimatizing a patient to therapy for treatment ofsleep-disordered breathing, comprising: a sensor for determining a sleepstage of the patient, each sleep stage having a treatment pressureassociated therewith; a flow generator operable to, provide a supply ofpressurized breathable gas to the patient in dependence on the sleepstage of the patient and configured to adjust the treatment pressure ofthe breathable gas if the sensor determines that the sleep stage of thepatient changes.
 55. The PAP device of claim 54, wherein a firstpressure provided to the patient during a comparatively active sleepstage is lower than a second pressure provided to the patient during acomparatively inactive sleep state.
 56. The PAP device of claim 55,wherein the comparatively active sleep stage is REM sleep, and thecomparatively inactive sleep stage is NREM sleep.
 57. The PAP device ofclaim 54, wherein the flow generator is further configured, for eachsleep stage, to initially provide the breathable gas at a limitedpressure lower than the treatment pressure associated with the sleepstage, and ramp up the pressure of the breathable gas from the limitedpressure to the treatment pressure associated with the sleep stage. 58.The PAP device of claim 54, wherein the flow generator provides thebreathable gas at a low pressure when the sensor indicates that thepatient is awake.
 59. A method of acclimatizing a patient to therapy fortreatment of sleep-disordered breathing, the method comprising:providing a supply of pressurized breathable gas to the patient for apredetermined settling time at a limited pressure; providing thebreathable gas at a full treatment pressure after the predeterminedsettling time; wherein the limited pressure is lower than the fulltreatment pressure.
 60. The method of claim 59, wherein thepredetermined settling time corresponds to an amount of time it takesthe patient to fall asleep.
 61. The method of claim 59, wherein thebreathable gas is provided at a pressure lower than the limitedpressure, the pressure being ramped up to the limited pressure duringthe predetermined settling time.
 62. The method of claim 59, whereinafter the predetermined settling time, the breathable gas is provided ata pressure lower than the full treatment pressure, the pressure beingramped up to the full treatment pressure while the patient is asleep.63. The method of claim 59, wherein the breathable gas is provided at apressure lower than the limited pressure, the pressure being ramped upto the limited pressure during the predetermined settling time, andwherein after the predetermined settling time, the breathable gas isprovided at a pressure lower than the full treatment pressure, thepressure being ramped up to the full treatment pressure while thepatient is asleep.
 64. The method of claim 59, wherein the settling timeis 1 hour.
 65. The method of claim 61, further comprising specifying anamount of time in which the pressure is ramped up to the full treatmentpressure.
 66. The method of claim 63, further comprising specifying anamount of time in which the pressure is ramped up to the full treatmentpressure.
 67. The method of claim 59, further comprising: providing aplurality of treatment sessions; and, increasing the limited pressureprovided during the settling time in successive treatment sessions. 68.The method of claim 59, further comprising: providing a plurality oftreatment sessions; and, reducing the settling time in successivetreatment sessions.
 69. The method of claim 68, further comprisingreducing the settling time in successive treatment sessions.
 70. Themethod of claim 60, further comprising extending the settling time apredetermined amount of time based on a patient-initiated signal. 71.The method of claim 70, wherein the settling time is extended 30minutes.
 72. The method of claim 70, further comprising: storing anumber of times the patient extends the settling time; and, adjustingthe settling time for future treatment sessions based on the number oftimes the patient extends the settling time.
 73. A system foracclimatizing a patient to therapy for treatment of sleep-disorderedbreathing, comprising: a flow generator operable to provide a supply ofpressurized breathable gas to the patient for a predetermined settlingtime at a limited pressure and operable to provide the breathable gas ata full treatment pressure after the predetermined settling time; whereinthe limited pressure is lower than the full treatment pressure.
 74. Thesystem of claim 73, wherein the predetermined settling time correspondsto an amount of time it takes the patient to fall asleep.
 75. The systemof claim 73, wherein the flow generator is configured to provide thebreathable gas at a pressure lower than the limited pressure, andfurther configured to ramp up to the limited pressure during thepredetermined settling time.
 76. The system of claim 73, wherein afterthe predetermined settling time, the flow generator is configured toprovide the breathable gas at a pressure lower than the full treatmentpressure, and further configured to ramp up to the full treatmentpressure while the patient is asleep.
 77. The system of claim 73,wherein the flow generator is configured to provide the breathable gasat a pressure lower than the limited pressure, and to ramp up to thelimited pressure during the predetermined settling time, and furtherconfigured to provide the breathable gas at a pressure lower than thefull treatment pressure, and to ramp up to the full treatment pressurewhile the patient is asleep.
 78. The system of claim 73, wherein thesettling time is 1 hour.
 79. The system of claim 76, wherein the flowgenerator is configured to accept user input, the user input specifyingan amount of time in which the pressure is ramped up to the fulltreatment pressure.
 80. The system of claim 77, wherein the flowgenerator is configured to accept user input, the user input specifyingan amount of time in which the pressure is ramped up to the fulltreatment pressure.
 81. The system of claim 73, wherein the therapy isprovided over a plurality of treatment sessions, and wherein the flowgenerator is configured to increase the limited pressure provided duringthe settling time in successive treatment sessions.
 82. The system ofclaim 73, wherein the therapy is provided over a plurality of treatmentsessions, and wherein the flow generator is configured to reduce thesettling time in successive treatment sessions.
 83. The system of claim82, wherein the flow generator is configured to reduce the settling timein successive treatment sessions.
 84. The system of claim 83, furthercomprising a mechanism for extending the settling time a predeterminedamount of time based on a patient-initiated signal.
 85. The system ofclaim 84, wherein the settling time is extended 30 minutes.
 86. Thesystem of claim 70, further comprising: a storage medium storing anumber of times the patient extends the settling time; wherein the flowgenerator is operable to adjust the settling time for future treatmentsessions based on the number of times the patient extends the settlingtime stored in the storage medium.
 87. A method of acclimatizing apatient to therapy for treatment of sleep-disordered breathing, themethod comprising: treating the patient using a PAP device; compilingpatient compliance data during the treatment; processing the patientcompliance data to identify problems associated with the treatment; and,comparing any identified problems to a solutions database.
 88. Themethod of claim 87, further comprising generating a recommendation as tohow to alleviate any identified problems.
 89. The method of claim 88,further comprising displaying the recommendation to the patient.
 90. Themethod of claim 88, further comprising advising the patient to visit asleep lab when a solution to an identified problem cannot be generated.91. The method of claim 87, wherein the patient compliance datacomprises changes in AHI, changes in leak level, and/or a number ofmask-off events.
 92. A system for acclimatizing a patient to therapy fortreatment of sleep-disordered breathing, comprising: a PAP deviceoperable to provide a supply of pressurized breathable gas to thepatient; and, a computer-mediated compliance monitoring package operableto execute the following steps of: compiling patient compliance dataduring the treatment; processing the patient compliance data to identifyproblems associated with the treatment; and, comparing any identifiedproblems to a solutions database.
 93. The system of claim 92, whereinthe compliance monitoring package is further operable to generate arecommendation as to how to alleviate any identified problems.
 94. Thesystem of claim 93, wherein the compliance monitoring package is furtheroperable to display the recommendation to the patient.
 95. The system ofclaim 93, wherein the compliance monitoring package is further operableto advise the patient to visit a sleep lab when a solution to anidentified problem cannot be generated.
 96. The system of claim 92,wherein the patient compliance data comprises changes in AHI, changes inleak level, and/or a number of mask-off events.